GAMP 5

The acronym GAMP 5 refers to "Good Automatic Manufacturing Practices issue 5", document.  Although GAMP 5 has no legal standing and is purely advisory, it does contain information and methodologies that are of interest to anyone engaged in validation activities within the cGMP regulated environment.   However; the reality of the situation is that our regulatory requirements for cGMP are published in 21 CFR Part 820/210/211/11 and other government issued edicts.

A company compliant with its regulatory requirements will have written its own equivalent of the GAMP 1/2/3/4/5 series. Only difference is; it will have titled them, Company Regulatory Practices and Procedures (CRPP) (or something similar), and they will be specific to the company.

All the GAMP 5 guidance documents have been authored by committees, and not everybody in a committee can get their own say. So there is often contentious material, statements and or methods included.

GAMP 5 compliance documents should be closely studied and the requirements, as applicable to your company’s activities, should be extrapolated and developed into your quality policies and procedures manual. This manual should then be the definitive authority on all Validation Online company matters.

The GAMP 5 committee has tried to be all things to all people, and in the opinion of many fail to be specific enough to be used as anything other than a discussion document. On the other hand; the work put in to developing your own RPP pays endless dividends, since it will document the responsibilities of all personnel, along with defining the scope of all company qualification processes. It should become a master reference document and its use will ensure that all your company regulatory activities will be compliant with the appropriate regulations.

GAMP 5

The GAMP 5 standard, allows a degree of flexibility when applying validation to the great variety of medical devices, processes, and manufacturing facilities, since it is not possible to state in one document all of the specific validation elements that are applicable. However, a general application of several broad concepts can be used successfully as guidance for validation Online in GAMP 5 demonstrates. These broad concepts provide an acceptable framework for building a comprehensive approach to software validation.

The GAMP 5 Guide for Validation of Automated Systems, has been released in December 2001 in Amsterdam. The guide aims to assist companies in the healthcare industries to achieve validated and compliant automated systems.

It provides guidance to the suppliers of those GAMP 5  automated systems on their development and maintenance by following good practice, and assists the suppliers in producing the necessary documentation required to support GAMP 5 validation concepts.

The GAMP 5 guidance document is a significant advance on previous versions of this widely accepted guidance on validation Online of automated systems. The complete document has been revisited and refined to reflect current regulatory expectations and good practice. It has been considerably enhanced and restructured, following principles and recommendations defined by the Industry Board.  However one must remember GAMP 5 is only a guide.

GAMP 5

The regulators mandate that all good automated manufacturing processes and methods used to produce a regulated product must be documented and be company approved.  In the majority of cases this requirement is fulfilled by using a standard operating practice documents (SOP’s) to encapsulate the GAMP 5 methodology chosen.  The original SOP once approved will reside in a safe and secure location in change control (this is a regularly audited requirement).

It really depends on your company practices and procedure (which also must be documented and approved) as to whether the GAMP 5 doctrine is in electronic format with; or without, e signatures.  Security of this document is initially by physical access and then by a series of cascading passwords.  The cascade must ensure that the person accessing the document can only access the document to the level that the company has authorized. Continuous control of all issued copies must be maintained by change control.

Change control must at all times (another regularly audited point) know the location of all the SOP copies in circulation and must have the capability to be able to recall them for incorporation of amendments or destruction.

As an auditor, I have audited for these features for many years and I have never found a case of un-authorized SOP changes.  I have found many cases where the operators failed to follow the SOP containing the GAMP 5 procedures.  This always puzzles me; why shoot yourself in the foot over something so obvious, but a glance through the warning letters shows this is still one of the major causes of FDA citations.